{"protocolSection":{"identificationModule":{"nctId":"NCT03595579","orgStudyIdInfo":{"id":"AXS-05-MDD-201"},"organization":{"fullName":"Axsome Therapeutics, Inc.","class":"INDUSTRY"},"briefTitle":"Assessing Symptomatic Clinical Episodes in Depression","officialTitle":"A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder","acronym":"ASCEND"},"statusModule":{"statusVerifiedDate":"2021-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-05-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"completionDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"studyFirstSubmitDate":"2018-06-20","studyFirstSubmitQcDate":"2018-07-12","studyFirstPostDateStruct":{"date":"2018-07-23","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-07-30","resultsFirstSubmitQcDate":"2021-09-22","resultsFirstPostDateStruct":{"date":"2021-09-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-09-22","lastUpdatePostDateStruct":{"date":"2021-09-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Axsome Therapeutics, Inc.","class":"INDUSTRY"}},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.","detailedDescription":"This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["AXS-05","Major Depressive Disorder","MDD","Axsome","Depression","Dextromethorphan","Bupropion","Sigma-1","NDMA","ASCEND"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":97,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"AXS-05","type":"EXPERIMENTAL","interventionNames":["Drug: AXS-05"]},{"label":"Bupropion","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Bupropion"]}],"interventions":[{"type":"DRUG","name":"AXS-05","description":"AXS-05 taken twice daily for 6 weeks.","armGroupLabels":["AXS-05"]},{"type":"DRUG","name":"Bupropion","description":"Bupropion taken twice daily for 6 weeks.","armGroupLabels":["Bupropion"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"MADRS Score - Overall Change From Baseline","description":"The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. 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Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. 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